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Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury

NCT00810940 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2010-12-08

No results posted yet for this study

Summary

This is a randomized, controlled clinical trial at three sites to determine the safety and preliminary efficacy of the study drug to treat severe head trauma (GCS 4-8). It is hypothesized that the drug may lower pressure in the brain, reduce mortality and the patient may have improved neurological function following treatment.

Conditions

  • Severe Head Trauma

Interventions

DRUG

AbelaDrug200

IV 200 ml 28%drug in D5W every six hours, 10 min. duration, until ICP \< 20 mmHg, then IV 100 ml same schedule for 24 hours

DRUG

mannitol

mannitol plus standard treatment

Sponsors & Collaborators

  • Ohio State University

    collaborator OTHER

  • University of California, Irvine

    collaborator OTHER

  • Dr. Mahajan's Hospital & Industrial Trauma Centre

    collaborator OTHER

  • Abela Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00810940 on ClinicalTrials.gov